Your project: | Photostability Testing |
Procedure: | Guideline 3AQ18A, previous title: ICH Q1B, „Photostability Testing for New Substances and Products“, CPMP/ICH/279/95, Legislative basis: Directive 75/318/EEC |
Our offer: | Performing photostability testing of your samples as your contract laboratory; documentation, and re-shipment of exposed samples; Optional: Analytical work on exposed samples |
Methodology: | „confirmatory“: 10-12 hours illumination by means of Xenon-light, precisely meeting “not less than 1,2 mio lux hours” and “not less than 200 Watt hours/m2” integrated near ultraviolet UV energy (“option 1”); same minimum requirments, but alternate “option 2” by means of “cool white fluorescent lamp” and “near UV lamps”„accelerated“: light challenge exceeding the minimum requirements significantly with regard to time and to the UV compartment of the light |
Our competence: | Broad expertise in photostability testing of starting materials, bulk products, finished and finally packed products, and packaging components;
Availability of Xenon-light-cabinets with “cool air” ventilation and also with water-cooled stainless steel bottom; Availability of cabinets with “cool white fluorescent” lamps and “near UV lamps” and free choice of temperature and humidity; Documented qualification and calibration of these devices; Calibration by chemical actinometry; Optional chemical actinometry during your test; Preparation of self-explanatory reports with comprehensive description of the method and technique applied strictly following ICH Q1B; On request: Investigation of appearance, content, and purity of exposed samples, e.g. by HPLC, TLC, GC We perform the illumination at short notice practically immediately after receipt of your samples; Re-shipment of exposed samples can be arranged within 48 hours after receipt. |
Your dialogue partner: | Natalie Nicola, Biologist Tel: 0049 (0)7251 72484-26 Fax 0049 (0)7251 72484-29 info(Replace this parenthesis with the @ sign)techpharm.de |